Humacyte’s ATEV Results Presented From V007 Phase 3 AV Access Trial

November 13, 2024—Humacyte, Inc. recently announced the presentation of results from the V007 phase 3 clinical trial of the company’s acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for patients with end-stage renal disease. In July 2024, the company announced the top-line results from the trial.

The company reported that in the coprimary endpoints of the trial, the ATEV demonstrated superior function and patency at 6 and 12 months compared to autogenous fistula, which is the current standard of care for hemodialysis patients.

Additionally, the ATEV showed superior function and patency in female, obese, and diabetic patients, each of which is a high-need subgroup with historically poor outcomes with AV fistula procedures, noted Humacyte.

The findings were presented by Mohamad A. Hussain, MD, at Kidney Week 2024, the annual meeting of the American Society of Nephrology held October 23-27 in San Diego, California. Dr. Hussain is Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School in Boston, Massachusetts.

According to Humacyte, the V007 phase 3 trial is a prospective, multicenter, randomized clinical study that enrolled 242 hemodialysis patients in the United States. Patients in the study were randomly assigned to receive either the ATEV or an AV fistula for hemodialysis access. The patients were followed for up to 24 months.

Under the statistical analysis plan for the trial, the primary efficacy assessment compared functional patency (usability for hemodialysis access) at 6 months and secondary patency (blood flow through the conduit) at 12 months as the coprimary endpoints.

As summarized in the company’s press release, the findings that were presented at Kidney Week 2024 included the following for patients implanted with the ATEV compared to those receiving AV fistula, respectively:

• Functional patency at 6 months was 81.3% versus 66.4%.
• Secondary patency at 12 months was 68.3% versus 62.2%.
• The joint test for superiority at 6 and 12 months was statistically significant (P = .0071).
• Duration of hemodialysis over the first 12 months was significantly longer (P = .0162).

In the subgroup analysis performed in the three patient groups that historically have poor outcomes with AV fistula procedures, the results showed the following:

1. Female patients (n = 70)
   • Patency rates were significantly higher at 6 months and 1 year (P < .0001).
   • Duration of hemodialysis over the first 12 months was significantly longer (8.3 months vs 5.0 months; P = .0011).
2. Obese patients (body mass index ≥ 30; n = 93)
   • Patency rates at 6 months and 1 year were significantly higher (P = .0001).
   • Duration of hemodialysis over the first 12 months was significantly longer (7.7 months vs 4.5 months; P = .002).
3. Diabetic patients (n = 165)
   • Patency rates at 6 months and 1 year were significantly higher (P = .0024).
   • Duration of hemodialysis over the first 12 months was significantly longer (7.4 months vs 5.5 months; P = .0155).

The company further reported the following for patients treated with ATEV compared to AV fistula:

• The rate of infection was low in both treatment arms. Patients experiencing access-related infections was 9.1% versus 9.9% (12 vs 14 total events).
• The occurrence of treatment-emergent adverse events was 98.3% versus 96.7% (1,211 vs 828 total events).
• The largest area of difference in adverse events was in thrombosis with 52.1% versus 9.1% (126 vs 12 total events).
• The majority (94%) of ATEV patients with thrombosis were successfully treated.

“These results show that availability of the ATEV, a biologic conduit, could be game changing in improving arteriovenous access in many hemodialysis patients,” commented Dr. Hussain in Humacyte’s press release. “I was particularly pleased to see positive results in female, obese, and diabetic patients, groups which typically have poor outcomes with autogenous fistula procedures and historically limited treatment alternatives for hemodialysis access. The significantly higher duration of access over 1 year in these underserved patients could greatly reduce reliance on catheters for arteriovenous access.”

The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency, advised Humacyte.As previously announced, based on guidance from the FDA, the proper or generic (nonbrand) name “acellular tissue engineered vessel,” or ATEV, has replaced the term “human acellular vessel,” or HAV, that was previously used for Humacyte’s bioengineered vessel candidate.